We are currently in the mode of picking on the FDA operations and shenanigans. This is an endless cycle of woe is me we go through here, especially while we are all sitting waiting for the next "catalyst". (I'm bad at it as well, but am trying to be self aware) We all bellyache that the FDA and the system has screwed us in the past, but yet we all talk about how "this time we are going to really prove it and knock it out of the park with CDxx)"
I hope it is all true that we will, however we should be somewhat circumspect that if we have been screwed over up to this point, what has changed that will impact the way we are treated in the future. What will change that will impact the direction of cydy? There have been numerous knives in the back, banana peels thown out in front of us, tacks and oil slicks from the cars ahead of us, all along our way to kick the ball Lucy is holding. If we come back with big results for NASH what will really change?
FDA says good, now apply for BTD. Lets schedule a meeting to discuss how you apply for BTD... does May 15 work in your schedule? If not lets do July 24. After that you should have enough info to get started on the application. Oh... hey lets just do a combo meeting at the same time and review your LH protocol at that meeting in July.... great! see you then!.
That's how this will play out. We have to adapt, improvise and overcome. We need to find more or other ways to various approvals and potential cash flow. They have really had their boot on our neck so far, what is another couple years to bleed us dry.
Theres talk of SEC investigations, but the DOJ/SEC is so politicized that all decisions are political about who gets investigated and prosecuted. I can assure you that cydy has no political pull or friends in the system. In fact it is quite the opposite. If cydy makes much of a stink they are likely to get prosecuted just to make them shut up. We have no choice but to step up and say "thank you sir, may i have another"
If you think about it, progress is made, despite the FDA and government actions, not because of their actions. It has grown into such a beast that it has lost its mission. Essentially the FDA acts like the old asian father meme every time we show up with good results. "You got A? why not A+?"
Well there's my pessimism. Maybe some of you can tell me where i'm way off base. Im praying that NP and CR are bobbing and weaving and searching for new ways to fight the system.
I hope it is all true that we will, however we should be somewhat circumspect that if we have been screwed over up to this point, what has changed that will impact the way we are treated in the future. What will change that will impact the direction of cydy? There have been numerous knives in the back, banana peels thown out in front of us, tacks and oil slicks from the cars ahead of us, all along our way to kick the ball Lucy is holding. If we come back with big results for NASH what will really change?
FDA says good, now apply for BTD. Lets schedule a meeting to discuss how you apply for BTD... does May 15 work in your schedule? If not lets do July 24. After that you should have enough info to get started on the application. Oh... hey lets just do a combo meeting at the same time and review your LH protocol at that meeting in July.... great! see you then!.
That's how this will play out. We have to adapt, improvise and overcome. We need to find more or other ways to various approvals and potential cash flow. They have really had their boot on our neck so far, what is another couple years to bleed us dry.
Theres talk of SEC investigations, but the DOJ/SEC is so politicized that all decisions are political about who gets investigated and prosecuted. I can assure you that cydy has no political pull or friends in the system. In fact it is quite the opposite. If cydy makes much of a stink they are likely to get prosecuted just to make them shut up. We have no choice but to step up and say "thank you sir, may i have another"
If you think about it, progress is made, despite the FDA and government actions, not because of their actions. It has grown into such a beast that it has lost its mission. Essentially the FDA acts like the old asian father meme every time we show up with good results. "You got A? why not A+?"
Well there's my pessimism. Maybe some of you can tell me where i'm way off base. Im praying that NP and CR are bobbing and weaving and searching for new ways to fight the system.
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